Senior Software Quality Engineer

Corin is seeking an experienced and motivated Senior Software Quality Engineer to support and oversee system and software development activities across our Global Technology Team. This is a critical role within our orthopaedic medical device business, ensuring that software and system development processes comply with FDA, ISO and European Medical Device regulations and standards.

• Provide expert quality assurance guidance and oversight for software and system development activities.
• Partner with cross-functional global teams throughout the product development lifecycle.
• Review software project documentation to ensure compliance with regulatory and quality requirements.
• Participate in design reviews, software and system risk assessments, and project milestone reviews.
• Collaborate with Software and Product Development teams to define requirements and establish appropriate verification and validation strategies.

• Support the application, compliance and continuous improvement of policies, procedures and quality system documentation related to:
  • Software development and validation
  • Risk management
  • Cybersecurity compliance
  • Software and system verification and validation
  • Quality investigations
  • Requirements traceability
• Perform gap assessments of Software Development Lifecycle (SDLC) processes against relevant standards, including IEC 62304 and computer system validation requirements.
• Develop and implement procedures, controls and quality processes that support a compliant SDLC framework.
• Promote awareness and understanding of applicable regulatory requirements, quality standards and company procedures across the organization.

• Provide Quality Assurance oversight for software suppliers and service providers.
• Interface with suppliers to ensure software deliverables and specifications meet defined requirements.
• Lead supplier audits, assessments and qualification activities for software vendors and service providers.

• Lead and support Corrective and Preventive Actions (CAPA), quality investigations and complaint handling activities.
• Conduct internal audits of Quality System processes to verify compliance with regulatory requirements and internal procedures.
• Support external regulatory and certification audits, including preparation, participation and responses to audit findings.
• Identify and implement improvements to Quality Management System processes and Standard Operating Procedures (SOPs) to ensure ongoing compliance and operational effectiveness.

You are a collaborative quality professional with strong experience in medical device software development and quality systems. You have a passion for compliance, continuous improvement and innovation, and are comfortable working across multiple projects in a fast-paced global environment.

• Bachelor's degree in Engineering, Life Sciences, Medical Technology or a related discipline.
• Minimum of 5–7 years’ experience within Quality Assurance, Medical Devices and Software Development environments.

• Strong working knowledge of:
  • ISO 13485
  • ISO 14971
  • IEC 62304
• Experience supporting product and software development life cycles.
• Knowledge of FDA regulations, including:
  • 21 CFR Part 820
  • 21 CFR Part 11
  • FDA software validation and software development guidance
• Ability to manage multiple projects and competing priorities effectively.
• Strong problem-solving skills and the ability to work independently and collaboratively.
• Excellent communication, stakeholder management and interpersonal skills.
• Self-motivated, results-oriented and quality-focused approach.
• Ability to drive continuous improvement and…